Background
Methods
Inclusion criterion | |
---|---|
RCTs of nsLBP not failing one of the eight exclusion criteria | |
Order | Exclusion criteria |
1 | Non-English language reports |
2 | Studies that were not RCTs or presented insufficient information for us to determine whether randomisation was used to allocate participants |
3 | Reports that self-identified as pilot/feasibility studies |
4 | Cross-over designs (because of limited utility in the LBP field) |
5 | RCTs with mixed samples (e.g. neck or thoracic pain in addition to LBP), samples of participants with radiating leg pain, or referred pain extending past the knee in reports where LBP was not described as non-specific, or samples including LBP specific pathology (e.g. cancer, ankylosing spondylitis, or disc herniation) or pregnancy |
6 | Trials using solely objective or psychological outcome measures |
7 | Non-inferiority designs |
8 | Follow-up studies with no new outcome measures, and multiple publications. In the case of multiple publications, we included the first published article and excluded subsequent publications |
Data extraction and analysis
Results
Framework of inclusion and exclusion criteria
Theme | Subthemes | n (%) | |
---|---|---|---|
1 | Anatomical area | Between costal margins and gluteal folds | 8 (5) |
Below scapulae and above gluteal folds | 3 (2) | ||
T6 or below | 2 (1) | ||
T7 or below | 2 (1) | ||
Low back or buttocks | 2 (1) | ||
Between L1 and gluteal folds | 2 (1) | ||
Between L1 and SI-joints | 1 (1) | ||
At or above waist level | 1 (1) | ||
2 | Symptoms and signs | Low back pain | 150 (89) |
With or without referred Leg pain | 27 (16) | ||
Back pain | 10 (6) | ||
Without referred leg pain | 7 (4) | ||
Pain exacerbated by movement | 5 (3) | ||
Limited movement | 3 (2) | ||
Stiffness | 2 (1) | ||
Tension | 2 (1) | ||
With referred leg pain | 1 (1) | ||
Pain at rest | 1 (1) | ||
Discomfort | 1 (1) | ||
3 | Patient-reported outcome measures with score thresholds for inclusion | Visual Analogue Scale* (0 to 100) | |
≥ 40 mm | 6 (4) | ||
≥ 30 mm | 4 (2) | ||
≥ 65 mm | 1 (1) | ||
≥ 35 mm | 1 (1) | ||
≥ 20 mm | 1 (1) | ||
≥ 10 mm | 1 (1) | ||
Oswestry Functional Disability Index (0 to 100%) | |||
≥ 30% | 2 (1) | ||
≥ 25% | 2 (1) | ||
≥ 20% | 1 (1) | ||
≥ 15% | 1 (1) | ||
Roland Morris Disability Questionnaire (0 to 24) | |||
≥ 3 points | 2 (1) | ||
≤ 4 points | 1 (1) | ||
≤ 5 points | 1 (1) | ||
Numeric Rating Scale (0 to 10) | |||
≥ 3 points | 1 (1) | ||
≥ 2 points | 1 (1) | ||
Von Korff Chronic Pain Grade (0 to 4) | |||
≥ Grade 1 | 1 (1) | ||
Hanover Ability Questionnaire (0 to 100%) | |||
≤ 70% | 1 (1) | ||
Short-From 36 | |||
“moderate pain and moderate disability (measured by adaptations of items 7 and 8 of SF-36)” | 1 (1) | ||
Brief Pain Inventory (0 to 10 on Average pain) | |||
“4 points on average pain last 6 months” | 1 (1) |
Themes | Subthemes | n (%) | |
---|---|---|---|
1 | Back-related condition | Spondylolisthesis | 35 (21) |
Spinal stenosis | 31 (18) | ||
Spondylolysis | 13 (8) | ||
Ankylosing spondylitisa | 8 (5) | ||
Structural deformity | 7 (4) | ||
Osteoporotic fracture | 6 (4) | ||
Congenital deformation | 6 (4) | ||
Disc disease | 3 (2) | ||
Sacroiliitis | 3 (2) | ||
Severe structural deformity | 3 (2) | ||
Scoliosis | 2 (1) | ||
Active structural deficit | 2 (1) | ||
Severe postural abnormality | 2 (1) | ||
2 | Specified, unspecified, implied systemic, rheumatologic or immunologic conditions | Inflammatory disease | 37 (22) |
Osteoporosis | 27 (16) | ||
Rheumatological disease | 13 (8) | ||
Rheumatoid arthritis | 12 (7) | ||
Fibromyalgia | 9 (5) | ||
Autoimmune disease | 4 (2) | ||
Reactive arthritisb | 2 (1) | ||
Bone disease | 2 (1) | ||
Osteoarthritis | 2 (1) | ||
Inflammatory arthritis | 1 (1) | ||
Arthritis | 1 (1) | ||
Systemic Lupus Erythematosus | 1 (1) | ||
Myofascial pain syndrome | 1 (1) | ||
Articular impairment | 1 (1) | ||
3 | Psychological | Psychiatric disorders | 35 (21) |
Depression | 11 (6) | ||
Severe psychiatric disorder | 8 (5) | ||
Impaired cognition | 7 (4) | ||
4 | Other systemic, unspecified | Systemic disease | 15 (9) |
Metabolic disease | 10 (6) | ||
Visceral disease | 9 (5) | ||
Endocrine disorder | 2 (1) | ||
Uterine disease | 1 (1) | ||
Thyroid dysfunction | 1 (1) | ||
5 | Trauma | 63 (37) | |
6 | Malignancy | 78 (46) | |
7 | Infectious | Infection | 42 (25) |
Infectious spondylopathy | 5 (3) | ||
Infectious disease | 4 (2) | ||
Previous infection | 1 (1) | ||
Abscess | 1 (1) | ||
8 | Cardiovascular | Cardiac disease /insufficiency | 32 (19) |
Vascular disease /insufficiency | 13 (8) | ||
Hypertension | 6 (4) | ||
Ischemic heart attack | 2 (1) | ||
Claudication | 2 (1) | ||
Aortic aneurysm | 1 (1) | ||
9 | Haematological | Bleeding disorders | 5 (3) |
Blood coagulation disorder | 2 (1) | ||
10 | Respiratory | Respiratory disease /insufficiency | 14 (8) |
11 | Gastrointestinal, liver or renal | Severe renal or hepatic disorder | 5 (3) |
Liver disease | 2 (1) | ||
Gastrointestinal disease | 2 (1) | ||
Abdominal hernia | 2 (1) | ||
Gastritis | 1 (1) | ||
Gastric ulcer | 1 (1) | ||
Crohn’s disease | 1 (1) | ||
Inguinal hernia | 1 (1) | ||
12 | Neurological, systemic | Myelopathy | 2 (1) |
Epilepsy | 2 (1) | ||
Seizure disorders | 1 (1) | ||
Muscular disease | 1 (1) | ||
Muscular dystrophy | 1 (1) | ||
13 | General indications of spinal pathology | Pathology or disease “such as” / “e.g” | 22 (13) |
Specific cause “such as” / “e.g” | 22 (13) | ||
Red flags indicating serious spinal pathology | 21 (12) | ||
Specific cause identified | 14 (8) | ||
Known or suspected serious pathology | 10 (6) | ||
Non-mechanical low back pain | 1 (1) | ||
14 | Neurological related to the back (symptoms or signs or specific conditions referable to involvement of the spinal cord or nerve roots) | Nerve root compromise | 44 (26) |
Neurological signs | 34 (20) | ||
Disc herniation | 30 (18) | ||
Sciatica | 17 (10) | ||
Radicular symptoms | 16 (9) | ||
Signs of nerve root irritation | 15 (9) | ||
Cauda equina syndrome | 14 (8) | ||
Radiation below knee | 13 (8) | ||
Radiculopathy | 10 (6) | ||
Progressive neurological signs | 4 (2) | ||
Radicular pain | 4 (2) | ||
Widespread neurological signs | 3 (2) | ||
Leg symptoms | 3 (2) | ||
Spondylolisthesis with radiculopathy | 1 (1) | ||
Cord compression | 1 (1) | ||
Paralysis | 1 (1) | ||
15 | Previous or scheduled surgery | 84 (50) | |
16 | Pregnancy-related | Pregnancy | 81 (48) |
Pre-eclampsia | 1 (1) | ||
17 | Medico-legal issues | 39 (23) | |
18 | Comorbidities | Comorbidities | 2 (1) |
Urine or faecal incontinence | 1 (1) | ||
19 | Exclusion for feasibility | Not understanding language | 28 (17) |
Other current treatment | 18 (11) | ||
Previous specific treatment | 17 (10) | ||
Medication | 13 (8) | ||
Contraindications for intervention | 8 (5) | ||
Cardiac pacemaker | 6 (4) | ||
Current alcohol abuse | 3 (2) | ||
Unable to commit to home-exercises | 3 (2) | ||
Fever on the day of examination | 3 (2) | ||
History of psychosis | 2 (1) | ||
History of alcohol abuse | 2 (1) | ||
Presence of yellow flags | 1 (1) | ||
20 | Miscellaneous | Obesity | |
Body Mass Index ≥30 | 4 (2) | ||
Body Mass Index ≥40 | 3 (2) | ||
Obesity (not specified) | 2 (1) | ||
Body Mass Index ≥35 | 1 (1) | ||
Body Mass Index ≥28 | 1 (1) | ||
Menstruation | 1 (1) | ||
Unable to sit on a stationary bike | 1 (1) | ||
Bad balance between trunk flexors and extensors | 1 (1) | ||
Inability to walk at least 100 m without interruption | 1 (1) | ||
Neurologic impairment | 1 (1) | ||
Behaviour precluding participation in group therapy | 1 (1) | ||
Evidence of distress | 1 (1) | ||
Patients unable to accurately locate the area of pain | 1 (1) | ||
Patient unable to walk without a walking aid | 1 (1) | ||
Suspected non-compliance | 1 (1) | ||
21 | Patient-reported outcome measures with score thresholds for exclusion | Visual Analogue Scale (0 to 100)c | |
≥ 60 mm | 2 (1) | ||
≥ 80 mm | 2 (1) | ||
Beck Depression Inventory (0 to 63) | |||
≥ 20 points | 1 (1) | ||
≥ 29 points | 1 (1) | ||
Bothersomeness scale (0 to 10) | |||
≤ 3 points | 1 (1) | ||
Numeric Rating Scale (0 to 10) | |||
≥ 80 points | 1 (1) |
Inclusion criteria
Demographics
Anatomical area (Table 2, theme one)
Symptoms and signs (Table 2, theme two)
Exclusion criteria
Conditions (Table 3, themes one to 12)
Symptoms, signs and other exclusion criteria (Table 3, themes 13 to 19)
‘Miscellaneous’ exclusion criteria (Table 3, theme 20)
Patient-reported outcome measure score thresholds (inclusion theme 3 and exclusion theme 21)
Discussion
Comparisons with existing research
Strengths and limitations
Recommendations for future nsLBP trials and future research
Criterion/a | Examples |
---|---|
Anatomical region | Pain between bottom of ribs and buttock creases |
If pain below buttock creases is excluded; state any explicit criteria for exclusions | Pain radiating below knee or objective neurological signs in leg |
Age | Adults – with restrictions by age only if good scientific/clinical reason |
Duration | Back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months |
Serious causes of LBP excluded | Malignancy, vertebral fracture, infections |
Rheumatologic conditions excluded | Ankylosing spondylitis or related conditions |
Systemic conditions excluded | Cardiovascular, respiratory, neurological, gastrointestinal, urogenital or related conditions |
Baseline severity for studies of treatment (i.e not prevention) | NRS/VAS ≥ 4/40, or ≥ 15% of score range of a disability measure (e.g 4/24 for RMDQ) |
Other patient-characteristics excluded | Pregnancy, medico-legal issues, not understanding language, previous or scheduled surgery, psychiatric disorders |
Study specific criteria | Workers or men or with/without depression |